Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival for patients with peritoneal carcinomatosis from colorectal cancer: a phase II study from a Chinese center

Abstract

Background: Peritoneal carcinomatosis (PC) is a difficult clinical challenge in colorectal cancer (CRC) because conventional treatment modalities could not produce significant survival benefit, which highlights the acute need for new treatment strategies. Our previous case-control study demonstrated the potential survival advantage of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) over CRS alone. This phase II study was to further investigate the efficacy and adverse events of CRS+HIPEC for Chinese patients with CRC PC.

Methods: A total of 60 consecutive CRC PC patients underwent 63 procedures consisting of CRS+HIPEC and postoperative chemotherapy, all by a designated team focusing on this combined treatment modality. All the clinico-pathological information was systematically integrated into a prospective database. The primary end point was disease-specific overall survival (OS), and the secondary end points were perioperative safety profiles.

Results: By the most recent database update, the median follow-up was 29.9 (range 3.5-108.9) months. The peritoneal cancer index (PCI) ≤20 was in 47.0% of patients, complete cytoreductive surgery (CC0-1) was performed in 53.0% of patients. The median OS was 16.0 (95% confidence interval [CI] 12.2-19.8) months, and the 1-, 2-, 3-, and 5-year survival rates were 70.5%, 34.2%, 22.0% and 22.0%, respectively. Mortality and grades 3 to 5 morbidity rates in postoperative 30 days were 0.0% and 30.2%, respectively. Univariate analysis identified 3 parameters with significant effects on OS: PCI ≤20, CC0-1 and adjuvant chemotherapy over 6 cycles. On multivariate analysis, however, only CC0-1 and adjuvant chemotherapy ≥6 cycles were found to be independent factors for OS benefit.

Discussion: CRS+HIPEC at a specialized treatment center could improve OS for selected CRC PC patients from China, with acceptable perioperative safety.

Figure 1. The flowchart of this phase II clinical study.

Initially 62 patients were enrolled into this study, and 2 were excluded. A total of 60 patients underwent 63 CRS+HIPEC procedures. CRS = cytoreductive surgery, HIPEC = hyperthermic intraperitoneal chemotherapy, SC = systemic chemotherapy, PIC = perioperative intraperitoneal chemotherapy.

Figure 2. Kaplan-Meier curves.

The disease-specific overall survival in patients with CRC PC treated by CRS+HIPEC and adjuvant chemotherapy regimen (a). The statistical significance in overall survival (OS) comparisons of those patients including PCI (b), CC (c) and postoperative adjuvant chemotherapy cycles (d). mo = months, CRC = colorectal cancer, PC = peritoneal carcinomatosis, CRS = cytoreductive surgery, HIPEC = perioperative intraperitoneal chemotherapy, PCI = peritoneal cancer index, CC = completeness of cytoreduction.